Singapore, March 16, 2010: Eli Lilly and Company, a leading innovation-driven global corporation and Acrux, an Australian drug delivery company, developing and commercializing a range of patented pharmaceutical products have entered into an exclusive worldwide license agreement for the potential commercialization of Acrux's experimental underarm testosterone solution (proposed tradename AXIRON).

 

The new drug application for AXIRON is currently under regulatory review by the U.S. Food and Drug Administration (FDA) for the treatment of testosterone deficiency (hypogonadism) in men.

 

Under the terms of the agreement, Lilly will receive exclusive worldwide rights to commercialize AXIRON. In exchange for these rights, Acrux will receive an upfront payment of $50 million plus $3 million on the transfer of manufacturing assets. Acrux is further eligible for $87 million upon the issuance of marketing authorization by the FDA, and up to $195 million in potential commercialization milestones, as well as royalty payments on future global sales if AXIRON is successfully commercialized. As a result of this transaction, Lilly expects to incur a charge to earnings in the first quarter of 2010 of approximately $.03 per share.

 

"The addition of AXIRON reinforces Lilly's commitment to men's health and, if approved, could provide a new treatment option for men suffering from low testosterone," said Bryce Carmine, president of Lilly's Bio-Medicines.

 

"We are delighted to build on our established relationship with Lilly and collaborate on the potential worldwide commercialization of AXIRON. Through Lilly's considerable global resources and leadership position in the field of men's health, Acrux now has the opportunity to achieve the full commercial potential of AXIRON," said Dr Richard Treagus, chief executive officer of Acrux.